The TAH-T temporary total artificial heart system is indicated as a bridge to cardiac transplantation in patients who are eligible due to the risk of imminent death due to biventricular failure. The total-temporal artificial heart is indicated in eligible transplant patients at risk of imminent death due to biventricular terminal failure. Persistent ventricular tachycardia, refractory cardiogenic shock, rejection of the biological heart transplant, cardiac amyloidosis, congenital heart conditions. The TAH-T system is designed for use in hospital during and after the surgical implantation of the TAH-T. The Freedom driver system used with 50cc and 70cc TAH-T is designed for intrahospital and extrahospital use. The TAH-T system with the Freedom driver system is indicated for use as a translational bridge in patients who are candidates for heart transplantation in whom the TAH-T has been implanted and are clinically stable.
SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System)Product Code: SYN-595000-001Supplied through Clinical Trial and SAS Category A